Positive indications – studies and publications

Migraine

The chronic migraine study is currently being carried out at ten clinics in Germany and Finland. The study has been delayed due to Covid-19, but is expected to be completed around the turn 2020/2021.

The results from an interim analysis of the first 53 patients were presented in May, 2019. The external data monitoring committee recommended that the study should continue according to plan, and that the number of patients participating in the study should remain unchanged. We interpret this as a strong indication that the study is likely to achieve the desired result.

Primary effect target: evaluate the effect of K.O.S. treatment through the decrease of the number of days/months with headaches with moderate to serious intensity.

Scope: <140 patients in nine clinics in Germany and Finland

Type: double-blind, randomized, placebo controlled

Inclusion: males/females in the 18-65 age bracket, migraine diagnosis <60 years of age, chronic migraine diagnosis< three months

Design: 50/50 randomized to active versus placebo treatment, 4 weeks screening, 6 weeks treatment, follow-up 4 weeks

 

Rhinitis

Our extensive rhinitis study is currently being conducted in 13 clinics in six countries in the EU and the UKand the last patient is expected to have completed treatment during the first half of 2021. The study includes 12 months of follow-ups which is why it will be completed one year later than the migraine study.

The purpose of the rhinitis study is to, along with previous trials that have been carried out, equip ourselves with strong arguments when it comes to compensatory decisions taken by insurance companies and public health institutions.

Primary effect target: evaluate the improvement effect of K.O.S. treatment on NAR (non-allergic rhinitis) with, among other things, Total Nasal Symptom Score (TNSS)

Scope: Around 300 patients in 13 clinics in six countries in the EU and the UK

Type: double-blind, randomized, placebo controlled

Inclusion: males/females in the 18-65 age bracket, rhinitis diagnosis >12 weeks, nasal congestion estimated at >2 (on a scale of 0-3)

Design: 50/50 randomized to active vs placebo treatment, 10 days screening, two treatments at four-week intervals, follow-ups with 12 weeks intervals for 12 months

 

Clinical studies and references

The effect of Chordate's treatment has been investigated in a number of studies over the years, where Chordate has often been the sponsor. These studies have been published in the articles below.

 

Rhinitis / Nasal congestion - studies with K.O.S

Ehnhage, A, Sahlstrand Johnsson P, et al Treatment of idiopathic rhinitis with kinetic oscillations – a multi- centre randomized controlled study. Acta Oto-laryngologica, 2016; 136(8):852-859

Juto JE, Axelsson M. Kinetic oscillation stimulation as treatment of non-allergic rhinitis: an RCT study. Acta Otolaryngol 2014; 134:506-12.

Fokkens et al. Rhinology Future Debates 2017 by EUFOREA: Novel treatments and surgical solutions in rhinology. Clinical Otolaryngology. 2018;1–10.

Migraine – studies with K.O.S

Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. Neurolmage: Clinical 2016; 451-459

Jan-Erik Juto, MSc, MD, PhD; Rolf G. Hallin, MD, PhD. Kinetic Oscillation Stimulation as Treatment of Acute Migraine: A Randomized, Controlled Pilot Study. Wiley Periodicals, Inc. 2014

Mechanism of action

Markus Jerling MD, Iwona Cygankiewicz, Nabil Al-Tawil, Borje Darpo, Anders Ljungström, Wojciech Zareba. Effects of intranasal kinetic oscillation stimulation on heart rate Variability. Ann Noninvasive Electrocardiol. 2017;e12474.

Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. NeuroImage: Clinical 12 (2016) 451–459

Other scientific references

Sarin S. The role of the nervous system in rhinitis. J Allergy Clin Immunol 2006; 118:999-1016.

Safwan S. Jaradeh, MD; Timothy L. Smith, MD, MPH; Laura Torrico, MD; Thomas E. Prieto, PhD; Todd A. Loehrl, MD; Ronald J. Darling, MD; Robert J. Toohill, MD, FACS. Autonomic Nervous System Evaluation of Patients With Vasomotor Rhinitis. Laryngoscope 2000; 110:1828–1831

Hellings P.W., Klimek L., Cingi C., Agache I., Akdis C., Bachert C., Bousquet J., Demoly P., Gevaert P., Hox V., Hupin C., Kalogjera L., Manole F., Mösges R., Mullol J., Muluk N.B., Muraro A. , Papadopoulos N., Pawankar R. , Rondon C. , Rundenko M., Seys S.F., Toskala E., Van Gerven L., Zhang L., Zhang N., Fokkens W.J. Non-Allergic Rhinitis: Position paper of the European Academy of Allergology and Clinical Immunology. Allergy. 2017

K. Scadding, H. H. Kariyawasam, G. Scadding, R. Mirakian, R. J. Buckley, T. Dixon, S. R. Durham, S. Farooque, N. Jones, S. Leech, S. M. Nasser, R. Powell, G. Roberts, G. Rotiroti, A. Simpson, H. Smith, A. T. Clark, BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007), Clin Exp Allergy. 2017;47:856–889.

Pete Smith, David Price, Richard Harvey, Andrew Simon Carney, Vicky Kritikos, Sinthia Z Bosnic-Anticevich, Louise Christian, Derek Skinner, Victoria Carter, Alice Marie Sybille Durieux. Medication-related costs of rhinitis in Australia: a NostraData cross sectional study of pharmacy purchases. Journal of Asthma and Allergy. 2017:10 153–161

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